Sildenafil-free base-containing film preparation and method for producing same

Abstract

The present invention provides a method for preparing a film comprising a high amount of a sildenafil free base uniformly dispersed therein and having a suitable thickness and size, as well as flexibility providing good handling stability and being not prone to breaking. The present invention also provides a sildenafil free base-containing film prepared from the method.

What is claimed is: 
     
       1. A method for preparing a sildenafil free base-containing film, comprising:
 drying a polymer solution in which a sildenafil free base as an active ingredient is dispersed, wherein the sildenafil free base has a particle size distribution in which a particle diameter (D10) corresponding to 10% of the distribution is about 8 μm to about 10 μm and a particle diameter (D90) corresponding to 90% of the distribution is about 67 μm to 100 μm. 
 
     
     
       2. The method according to  claim 1 , wherein a solvent used in the polymer solution comprises water in an amount of 90 wt % or more relative to the weight of the polymer solution or more thereof so that the sildenafil free base is prevented from being dissolved. 
     
     
       3. The method according to  claim 2 , wherein the solvent used in the polymer solution comprises water in an amount of 95 wt % or more relative to the weight of the polymer solution or more thereof so that the sildenafil free base is prevented from being dissolved. 
     
     
       4. A method for preparing a sildenafil free base-containing film, comprising:
 dispersing a sildenafil free base in a solution obtained by dissolving a polymer and a plasticizer in a solvent comprising 90 wt % or more of water, and drying the solution to form a dried film, the sildenafil free base having a particle size distribution in which D10 is about 8 μm to about 10 μm and D90 is about 67 μm to 100 μm, 
 wherein the polymer is used in an amount of 20 to 45 wt %, the plasticizer is used in an amount of 4 to 20 wt %, and the sildenafil free base is used in an amount of 40 to 60 wt %, based on the total weight of the dried film. 
 
     
     
       5. The method according to  claim 1 , wherein the polymer has a viscosity of 15 cp or less when measured in an aqueous solution containing 2 wt % of the polymer. 
     
     
       6. The method according to  claim 5 , wherein the polymer is a mixture of a polymer having a viscosity of 15 cp or less and a polymer having a viscosity of 50 cp or more, each viscosity being measured in an aqueous solution containing 2 wt % of each polymer. 
     
     
       7. The method according to  claim 6 , wherein the polymer comprises pullulan, propylene glycol alginate and xanthan gum. 
     
     
       8. The method according to  claim 1 , wherein the solution further comprises a surfactant, a dispersing agent, or a mixture thereof. 
     
     
       9. The method according to  claim 1 , wherein the polymer comprises pullulan. 
     
     
       10. The method according to  claim 1 , wherein the polymer solution comprises a solvent used in an amount of 1.3 to 3.3 parts by weight based on 1 part by weight of the components of the film remained after drying. 
     
     
       11. A sildenafil free base-containing film, comprising a sildenafil free base uniformly dispersed in a film comprising pullulan as a polymer, the sildenafil free base having a particle size distribution in which a particle diameter (D10) corresponding to 10% of the distribution is 8 μm to about 10 μm and a particle diameter (D90) corresponding to 90% of the distribution is about 67 μm to 100 μm. 
     
     
       12. The sildenafil free base-containing film according to  claim 11 , which comprises glycerine as a plasticizer. 
     
     
       13. The sildenafil free base-containing film according to  claim 12 , which further comprises a surfactant, a dispersing agent, or a mixture thereof. 
     
     
       14. The sildenafil free base-containing film according to  claim 11 , wherein the polymer further comprises pullulan, propylene glycol alginate and xanthan gum.